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Medical Device R&D Regulatory Compliance Training - Live Webinars, Recordings & CDs


4
/ May
Tuesday-2021
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
- Speaker: John E Lincoln
- Product ID: 701898
- Duration: 90 Min
* Per Attendee
$199
$199
Recorded/CD

How to Prepare a Standard Operating Procedure (SOP)?
- Speaker: Dr. Afsaneh Motamed Khorasani
- Product ID: 705131
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Introduction to Root Cause Investigation for CAPA
- Speaker: Vanessa Lopez
- Product ID: 704409
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Implementing a Bullet Proof Quality System for FDA Audit Success
- Speaker: Meena Chettiar
- Product ID: 705400
- Duration: 60 Min
Recorded/CD

Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers
- Speaker: Meena Chettiar
- Product ID: 705401
- Duration: 60 Min
CD/Recorded
$349
$349
Recorded/CD

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
- Speaker: Vanessa Lopez
- Product ID: 704758
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Understanding FDA Design Verification and Validation Requirements for Medical Devices
- Speaker: Meena Chettiar
- Product ID: 705331
- Duration: 75 Min
CD/Recorded
$299
$299
Recorded/CD

Sterilization of Pharmaceutical Products and Medical Devices
- Speaker: Carl Patterson
- Product ID: 705310
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD
![Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan](/images/products/medium/705370.jpg)
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
- Speaker: Robert J Russell
- Product ID: 705370
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

You have a BI Positive or Product Sterility Positive - Now What?
- Speaker: Gerry O Dell
- Product ID: 703288
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Failure Mode Effects Analysis
- Speaker: Michael Abitz
- Product ID: 705333
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016
- Speaker: John E Lincoln
- Product ID: 705111
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
- Speaker: Angela Bazigos
- Product ID: 704529
- Duration: 90 Min
CD/Recorded
$249
$249
Recorded/CD

Process Challenge Device Development for EO Sterilization
- Speaker: Gerry O Dell
- Product ID: 703443
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Risk Analysis in Medical Device Design
- Speaker: Charles H Paul
- Product ID: 704803
- Duration: 60 Min
Recorded/CD

Technical Writing for Medical Products: SOPs, Investigations and Change Records
- Speaker: Regina Fullin
- Product ID: 704304
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

FDA Regulations for Environmental Monitoring (EM) Program
- Speaker: Joy McElroy
- Product ID: 704377
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Cell Based Assays: Development and Validation
- Speaker: Michael Simonian
- Product ID: 704528
- Duration: 60 Min
Recorded/CD

Human Factors Engineering in New Product Development
- Speaker: Tom Kramer
- Product ID: 705153
- Duration: 120 Min
CD/Recorded
$249
$249
Recorded/CD

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
- Speaker: John E Lincoln
- Product ID: 704848
- Duration: 90 Min
CD/Recorded
$249
$249
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